Eisai Announces Preclinical Research Findings Suggesting Novel I

Eisai Announces Preclinical Research Findings Suggesting Novel Infibitory Effect
on Tumor Metastasis for Anticancer Agent Halaven(R) at AACR 104th Annual Meeting 
Tokyo, Apr 10, 2013 - (JCN Newswire) -  Eisai Co., Ltd. announced today that it
has presented preclinical research findings suggesting a potential inhibitory
effect on tumor metastasis as a possible novel mechanism of action for
anticancer agent Halaven(R) (eribulin mesylate, "eribulin") at the
American Association for Cancer Research (AACR) 104th Annual Meeting
("AACR 2013"). 
Among the research findings presented by Eisai at AACR 2013 were gene
expression profiling (GEP) analyses of multiple cancer cell lines, which
confirmed that eribulin altered expression in epithelial-mesenchymal transition
(EMT) gene sets. EMT was first recognized in the early 1980s and was long
assumed to be a feature of embryogenesis in which embryonic epithelial cells
acquire mesenchymal characteristics that lead to cell migration1; however, EMT
has in recent years also been reported 2 to perform a role in numerous disease
states in adult stages and, particularly in the acquisition of EMT phenotypes
in epithelial cancer cells, to be highly relevant to the infiltration and
metastasis of cancer. 
Eisai also presented a dynamic contrast-enhanced magnetic resonance imaging
(DCE-MRI) analysis of human breast xenograft tumors in rats, which confirmed
that eribulin improved blood perfusion in the core of tumor tissues
("tumor core"). These findings indicated that eribulin reduces
hypoxia by improving blood perfusion in the tumor core. Based on reports3 that
cancer cells inside hypoxic tumor tissues acquire highly metastatic phenotypes,
eribulin is expected to potentially prevent hypoxia in the tumor core by
improving blood perfusion and thus work to inhibit metastasis. 
Eisai remains committed to delivering further scientific evidence aimed at
maximizing the value of eribulin, including on the agent's main effect as
a non-taxane microtubule dynamics inhibitor and in regard to its potential
inhibitory effect on tumor metastasis as suggested in the preclinical research
findings presented at AACR 2013. Through this and other endeavors, the company
seeks to make further contributions to meet the diverse needs of, and increase
the benefits provided to, patients with cancer and their families as well as
healthcare providers. 
About Halaven(R) (eribulin mesylate) 
Halaven, a non-taxane, microtubule dynamics inhibitor with a novel mechanism
of action, belongs to a class of antineoplastic agents, the halichondrins,
which are natural products isolated from the marine sponge Halichondria okadai.
It is believed to work by inhibiting the growth phase of microtubule dynamics
without affecting the shortening phase and sequestering tubulin into
nonproductive aggregates. 
In a Phase III clinical study (EMBRACE) conducted overseas of Halaven versus
treatment of physician's choice (TPC) in 762 patients with locally
recurrent or metastatic breast cancer previously treated with an anthracycline
and a taxane, Halaven indicated an extended overall survival (OS) of 2.5 months
(OS of 13.1 months versus 10.6 months, respectively; Hazard Ratio (HR) 0.81;
p=0.041) when compared to TPC. An updated analysis of OS (not
protocol-specified) in the EMBRACE study was also performed at the request of
European and U.S. regulatory authorities. These results demonstrated an
increase of 2.7 months in OS for Halaven compared with TPC (OS of 13.2 months
versus 10.5 months, respectively; HR 0:81; p=0.014). The most common adverse
reactions (events with an incidence rate of at least 25%) among patients
treated with Halaven were asthenia (fatigue), neutropenia, anemia, alopecia
(hair loss), peripheral neuropathy (numbness and tingling in arms, legs and/or
other parts of the body), nausea and constipation. The most common serious side
effects reported in patients receiving Halaven were neutropenia with or without
fever (4% and 2%, respectively). The most common adverse reaction resulting in
discontinuation of treatment with Halaven was peripheral neuropathy (5%).
Furthermore, in a Phase II clinical study conducted in Japan, Halaven was found
to possess excellent anticancer effects and tolerability in patients with
advanced or recurrent breast cancer who had previously undergone treatment. 
Halaven was first approved as a treatment for breast cancer in the United
States in November 2010, and is currently approved in more than 40 countries
worldwide, including European Union member states, Japan, Singapore and
Switzerland. In Japan, the drug has been approved to treat inoperable or
recurrent breast cancer and was launched in the country in July 2011.
Furthermore, with the aim of maximizing value of the drug, Eisai is currently
conducting late-stage clinical developments investigating the potential of
Halaven as a therapy in the treatment of breast cancer with fewer prior
treatments as well as soft-tissue sarcoma and non-small cell lung cancer. 
1. Hay ED. "The mesenchymal cell, its role in the embryo, and the
remarkable signaling mechanisms that create it' Dev Dyn. 2005; 233:
2. Mani SA, Guo W, Liao MJ, Eaton EN, Ayyanan A, Zhou AY, Brooks M, Reinhard
F, Zhang CC, Shipitsin M, Campbell LL, Polyak K, Brisken C, Yang J, Weinberg
RA. "The Epithelial-Mesenchymal Transition Generates Cells with Properties
of Stem Cells" Cell. 2008 May 16; 133(4): 704-715.
3. Sullivan R, Graham CH. "Hypoxia-driven selection of the metastatic
phenotype" Cancer Metastasis Rev. 2007; 26(2): 319-331. 
About Eisai 
Eisai Co., Ltd. (TSE: 4523; ADR: ESALY) is a research-based human health care
(hhc) company that discovers, develops and markets products throughout the
world. Eisai focuses its efforts in three therapeutic areas: integrative
neuroscience, including neurology and psychiatric medicines; integrative
oncology, which encompasses oncotherapy and supportive-care treatments; and
vascular/immunological reaction. Through a global network of research
facilities, manufacturing sites and marketing subsidiaries, Eisai actively
participates in all aspects of the worldwide healthcare system. For more
information about Eisai Co., Ltd., please visit www.eisai.com. 
Eisai Co., Ltd.
Public Relations Department
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